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JOB SUMMARY
Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations thought contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines though start-up.
JOB RESPONSIBILITIES
Exercise good judgment in balancing the risks for Pfizer in making budget and contractual decisions against the impacts to Pfizer clinical trial timelines.
Follow GPD processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials.
Work with partners to develop and oversee the global site budget process.
Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters.
Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.
Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies.
Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space.
Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space.
Has knowledge of the principles, concepts and theories in applicable business discipline.
Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements.
Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline.
Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to the achievement of business objectives at GPD or WSR Functional Line level - e.g., WSR Worldwide Safety, WSR Worldwide Regulatory Operations, GPD Clinical Development & Operations, etc.
QUALIFICATIONS / SKILLS
Basic Qualifications:
5+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor's degree.
Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities.
Balance of general business, compliance, finance, legal, and drug development experience.
Precise communications and presentation skills.
Ability to plan, identify and mitigate risks to site contacting timelines.
Demonstrated ability to lead by influence rather than positional power to accomplish critical deliverables.
Demonstrated success in working in a highly matrix-based organization.
Preferred Qualifications:
2+ years of experience in clinical development operations or clinical trial outsourcing and a US Juris Doctorate or equivalent legal degree.
Experience in drafting and negotiating of Clinical Trial Agreements with clinical trial sites in a global operation.
Purpose
Breakthroughs that change patients lives... At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
At Pfizer we care about our colleagues wellbeing and offer a range of great benefits for them, including:
Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options
.Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
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Date Posted: 14/11/2024
Job ID: 100375917
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German immigrants, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).
Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than US$1 billion in annual revenues.In 2020, 52% of the company's revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries